DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims
Claims 1-20 are pending and are examined in this Office Action.
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered material to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants (if backcrossing was used for the parents) should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
Specification
The disclosure is objected to because of the following informalities: the disclosure lists “PTA-TBD” where there should be an accession number for deposited seeds (Spec 60).
Appropriate correction is requested.
Claim Objections
Claims 1, 8, 11, and 18 are objected to because of the following informalities:
Claim 1 has “PTA-TBD” where there should be an Accession number.
Claim 11 recites “PTA-125789” and this is inconsistent with “PTA-TBD” which is recited in claim 1 and is disclosed in the paragraph disclosing the deposit of seeds (Spec 60). The references to the deposit should match.
Claims 8 and 18 each recite crossing a plant with itself. This recitation occurs multiple times in each of these claims. This is technically incorrect because crossing is between two different plant (Spec 6).
Appropriate correction is requested.
Claim Interpretation
Claims 3 and 4 are directed to a seed produced by crossing a plant of variety SG451 with a different maize plant and to a plant or plant part produced by growing the seed. This is interpreted to be limited to the F1 generation from the recited cross, with no additional generations of breeding steps.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to plants and seed of maize variety SG451 and methods of using them. Applicant defines the word “variety” as follows:
“VARIETY: A maize line or hybrid and minor genetic modifications there of that retain the overall genetics of the line including but not limited to a locus conversion, a mutation, a somoclonal variant, or gene-edited variant.” (Spec 21).
It is unclear what genetic modifications qualify as minor. It is unclear what is required to retain the overall genetics. A locus conversion, a mutation, and a variant are all derivatives produced by modifying a starting material, and it is unclear what starting material is being referred to in this context. As written this seems to state that the variety includes loci converted relative to its own loci and mutations relative to its own genome, and variations relative to its own genetic background. This is circular logic and renders this definition meaningless.
See Nautilus, Inc. v. Biosig Instruments, Inc, No. 13-369, in which the Supreme Court held that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.
With regard to “minor modifications”, the definition of “minor” according to the online merriam-webster dictionary is: “inferior in importance, size, or degree : comparatively unimportant” (downloaded from w w w.merriam-webster.com/dictionary/minor on May 29, 2024). It is unclear what “minor modifications” means as far as the scope of the definition for “variety” because it is unclear which of the disclosed traits would be considered of lesser importance. It is unclear what modifications can be made and still be considered within the scope of the “variety”.
With regard to “overall genetics”, the definition of “overall” according to the online Britannica dictionary is: “viewed as a whole or in general” (downloaded from w w w.britannica.com/dictionary/overall on May 29, 2024). It is unclear what is meant by “overall genetics” means as far as the scope of the definition of “variety”. How much of the genome can be altered and still be considered to have retained the “overall” genetics?
Applicant has stated that plants within a variety may have one or more locus conversions (Spec 14-15). This allows for an unlimited number of changed loci. In addition, claims 9, 11-14, and 19 are directed to plants with additional traits, transgenes, and locus conversions. The metes and bounds of what would be encompassed by these claims are completely unclear, especially since the loci are converted and traits/transgenes added relative to SG451, itself. This is analogous to a chemical compound that is being claimed as a derivative of a derivative of a derivative of itself. It is circular and is clearly undefined. This applies to locus conversions introduced via backcrossing and also to locus conversions introduced via gene-editing.
With regard to mutations, specifically, Pavadai et al (Journal of Phytology (2009) Vol. 1; pp. 444-447) teach that there are multiple different treatments that can be used to induce mutations in a plant’s genome, resulting in many different phenotypes, some of which were lethal (Pavadai 445). It is unclear how many mutations can be introduced and which characteristics can be changed by mutation and continue to be covered by the instant label of “variety SG451”. Are there any traits or genes that are essential to “variety SG451” that must remain unaltered relative to the deposited seeds? Are there any traits that must remain unaltered relative to the traits disclosed in Table 1?
With regard to variants, specifically, Barwale et al (Plant Cell Reports (1987) Vol. 6; pp. 365-368) teach that multiple different phenotypic variations were observed in somaclonal variants of soybean, including albino, abnormal leaves, different leaflet number, and dwarfs (Barwale 366). Somaclonal variation is also known to occur in maize. It is unclear how many variations can be introduced and which characteristics can be changed and continue to be covered by the instant label of “variety SG451”. Are there any traits or genes that are essential to “variety SG451” that must remain unaltered relative to the deposited seeds and/or relative to the traits disclosed in the trait table?
Therefore, given the definition of “variety” in the specification, and the definitions and examples found in the specification as set forth, above, plants of “variety SG451” are inclusive of locus conversions, mutants, transgenic versions and variants of a starting plant. Members of the variety could have an unlimited number of locus conversions introduced.
This arrives at a place where a plant of variety SG451 can have occasional variants relative to itself, or it has characteristics that are essentially the same as its own characteristics. This is circular logic that renders the metes and bound of the variety name indefinite. For example, there is a description of SG451 in Table 1 on pages 56-57 of the specification. It is unclear if the plants used to gather the data for Table 1 are plants of “line SG451” or if they are plants of “variety SG451”, which according to the definition of “variety” is a much broader genus than the line. Were the deposited seeds from SG451 in a generation of plants that were selfed after the doubled haploid breeding step without any outcrosses which would be seeds of “line SG451” which do not have any locus conversions, mutations, or variations (Spec 21; breeding history). Is the claimed variety inclusive of plants that have conversions, mutations, and variations relative to the plants described in this table? Is the claimed variety inclusive of plants that have conversion, mutations, and variations relative to the deposited seeds? If so, how many changes relative to this table and/or relative to the deposited seeds are allowed? What language in the claims makes any limitations on changes clear?
Claims 1 and 11 recite “representative seed of the variety having been deposited under ATCC accession number …”. Because this deposit does not have an accession number in claim 1 nor is the accession number included in the paragraph discussing the seed deposit in the specification (Spec 60), the recitation merely provides an alphanumeric that has no art accepted meaning. Furthermore, even when the deposit is perfected, it is unclear how the seed is “representative”. It is clear that the “variety” encompasses all kinds of genetic and phenotypic changes, perhaps these changes are relative to a plant grown from one of the deposited seeds, but it is unclear in what way the deposited seeds are “representative” of the variety because it is unclear what is required to remain constant and unchanged. It is unclear if the plants grown to collect the data in the trait table are from the same batch of seeds as those that will be deposited. Or were the seeds altered relative to the deposit before or after the traits in the trait table were documented?
Claims 9 and 11, specifically, are indefinite because each requires the “characteristics listed in Table 1”. Claims must be stand alone and must not refer to tables except for in exceptional circumstances (MPEP2173.05(s)). This is not an exceptional circumstance.
With regard to claims 9, 11, and 19, specifically, the claims are directed to a plant “having essentially the same morphological and physiological characteristics” of a plant of maize variety SG451/characteristics listed in Table 1. This adds two layers of confusion: 1) it is unclear that characteristics are required for a plant to be a member of the variety; 2) it is unclear what percentage of traits must be retained to have “essentially” all of them. The metes and bounds are completely unclear.
Lack of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds and plants of maize variety SG451 or plants and plant parts derived from said variety, and methods that utilize said variety. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of the variety is considered sufficient for most crop species to ensure public availability. It is noted that Applicant has indicated that they have made or will make a deposit of seeds (Spec 60) but they have not yet provided an accession number or date of deposit nor have they guaranteed that all restrictions to public availability will be irrevocably removed upon granting of a patent, nor have they stated if the deposit will be made under the Budapest Treaty or not. The Examiner must be informed if the deposit was not accepted under the Budapest Treaty, because in that case, the Examiner will need to verify viability testing has been successfully performed.
(a) If a deposit is made AND ACCEPTED under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Inadequate Written Description
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The instant claims are broadly drawn to plants and seeds of maize variety SG451, and plants and seed derived from said variety, and methods of using said variety.
As discussed, above, in the indefiniteness rejection, the specification provides such a broad definition of “variety” that the metes and bounds of what maize plants would be covered by “variety SG451” are completely unclear. It is clear that “variety SG451” at least includes locus conversions, mutants, transgenic versions and variants of a starting plant, and this encompasses an unlimited number of changes to the genome and to the phenotypes and characteristics of the plants.
It is known in the art that treating seeds with chemical mutagens such as EMS can lead to multitudes of mutations within the genome. See, for example, Lu et al. (Mol. Plant (2018) Vol. 11; pp. 496-540) who teach that in one experiment treating maize plants with EMS, the average number of base changes per line was 180; the mutations affected 82% of the protein coding genes (Lu 496, abstract) These changes could alter most of the traits listed in Table 1 as the description information for the instant variety (Spec 47-48). “An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.” MPEP 2163 I A.
Furthermore, the instant specification does not have a single embodiment of a plant produced by mutating the instant variety, inducing a variation into the variety, introducing a locus conversion, or introducing a transgene actually reduced to practice. Given that the underlying genetics can be dramatically changed with thousands of base changes, rearrangement, or substitutions in the genomic DNA, and the phenotypic, physiological and morphological characteristics can be changed due to multiple changes in traits as a result of the mutations, variations, conversions, or transgenes, the genus of mutant plants encompassed by the claims is not adequately described.
In the instant application, applicant has provided a non-limiting description of the plant traits (Spec 56-57). Because of the indefiniteness about the metes and bounds of “variety SG451”, it appears an unlimited number of alterations to the genome are encompassed, and therefore, the genetics are not adequately described at all.
Applicant describes a single embodiment of the claimed genus of “variety SG451” (Spec 56-57, Table 1); however, they did not describe the seeds that were used to grow the plants that were utilized to generate the traits in the table. Therefore, this single embodiment is not described at the level of genetics (structural features), only by phenotypic characteristics (functional features). NOTE: if Applicant perfects the biological deposit requirement by depositing seeds and providing the accession number and assurances about public availability, they must indicate if these seeds are identical to the seeds that were grown to generate the traits in Table 1, or if there are actually modifications or alterations between the seeds used for the trait table and the seeds that will be deposited.
With regard to claims 9, 11-14, and 19, specifically, these claims can have any number of additional locus conversions, transgenes, and/or mutations relative to “variety SG451”, which is already a genus having unlimited numbers of modifications relative to an unknown starting material. This inclusion of plants produced by an iterative process of continual modification and conversions renders the claims inclusive of a nearly infinitely large genus of plants.
It is known in the art that commercial maize varieties grown in the United States lack genetic variation with only three ancestors providing 50% of all the genes in this pool of commercial varieties (Moore (Farm Industry News (2008) pp. 1-3; especially page 3). Given the similarity in the genetic backgrounds, there could be substantial overlap between any given population of maize, and it is important for a grower to be able to determine if they are infringing.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, the definition of the word “variety” has broadened the scope of all claims such that corn plants with both genetic and phenotypic differences are encompassed. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed. Given the lack of a known shared structure (required background genetics that cannot be changed) and the lack of any particular, specific, required traits (function of genetics); and given the fact that there are zero species reduced to practice, the genus of locus conversions, mutants, transgenics, and variants encompassed by the claims has not been adequately described.
Close Prior Art
Popi, J. (US Patent No. 7,205,464 B1; issued on April 17, 2007) teaches corn variety I135160 which shares the majority of the traits with the instant variety (Popi cols. 11-12; Spec (56-57). The varieties differ in the glume color, silk color, and ear position, and they would developed by breeding programs using different germplasm (different parent plants) (Popi col. 11; Spec 21).
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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